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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis MP XRay System, Model number 5904466

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  Class 2 Device Recall AXIOM Artis MP XRay System, Model number 5904466 see related information
Date Initiated by Firm January 31, 2007
Date Posted March 08, 2007
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-0578-2007
Recall Event ID 37389
510(K)Number K010721  
Product Classification Angiographic x-ray system - Product Code IZI
Product AXIOM Artis MP, Angiographic x-ray system, model number 5904466
Code Information Model number number 5904466 - serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20158, 20165, 20170, 20171, 20172, 20175, 20178, 20179, 20180, 20181, 20182, 20183, 20185, 20188, 20196, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, and 20303. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 C-arm gantry could rapidly descend without command during use.
FDA Determined
Cause 2		 Other
Action In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
Quantity in Commerce 62 units
Distribution The products were shipped to medical facilities nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL CORP.
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